FDA applicant
Life Design Systems, Inc.
FDA records 29 decisions for Life Design Systems, Inc. (Milwaukee, WI) from 1982 to 1992: 29 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and BYE (Attachment, Breathing, Positive End Expiratory…). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Life Design Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Life Design Systems, Inc. since 2007.
Recalls per year
1in 2008
Class I Class II/III not classified
Planning a device like Life Design Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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